Recent Updates
Recently added Catalysts

PF-06650833

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Apr 7, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment729
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04413617TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATEPHASE2 COMPLETED 460Jul 29, 2020Feb 7, 2022Apr 7, 2023144 Bulgaria, Canada +8
NCT02996500Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To MethotrexatePHASE2 COMPLETED 269Nov 10, 2016Aug 15, 2018Feb 27, 2020103 United States, Australia +17
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12
BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12

DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.

Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
Baseline and Week 12

The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.

Secondary Endpoints
DAS28-CRP Remission (<2.6) Rates at Week 24
Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
From first dose of study intervention (Day 1) to Week 28
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
From BL to Week 28
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-06650833 + tofacitinibEXPERIMENTAL -
PF-06650833 + PF-06651600EXPERIMENTAL -
PF-06650833EXPERIMENTAL -
PF-06651600EXPERIMENTAL -
TofacitinibEXPERIMENTAL -
Arm 1: 20 mg QDEXPERIMENTALPF-06650833 , 20 mg QD
Arm 2: 60 mg QDEXPERIMENTALPF-06650833, 60 mg QD
Arm 3: 200 mg QDEXPERIMENTALPf-06650833, 200 mg QD
Arm 4: 400 mg QDEXPERIMENTALPF-06650833, 400 mg QD
PlaceboPLACEBO_COMPARATORPlacebo, 0 mg BID
Arm 5: TofacitinibACTIVE_COMPARATORTofacitinib 5 mg BID
Interventions
NameTypeDescription
PF-06650833DRUG400 mg
PF-06651600DRUG100 mg
TofacitinibDRUG11 mg
PlaceboDRUGPlacebo
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites144

Inclusion Criteria: * Male or female participants between the ages of 18 and 70 years. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Diagnosis of RA and meeting the 2010 American...

Countries:BulgariaCanadaChileCzechiaGeorgiaHungaryPolandSlovakiaSpainUkraineUnited StatesAustraliaBosnia and HerzegovinaCroatiaGermanyMexicoRomaniaRussiaSerbiaSouth KoreaTaiwan
Unlock Eligibility Criteria